Adherence Monitoring For Substance Abuse Clinical Trials

Completed

• Conditions: Medication Adherence

• Registration Number: NCT01867476
• Lead Sponsor: California Pacific Medical Center Research Institute

Brief Summary

The purpose of this study is to determine the feasibility and accuracy of an automated adherence monitoring system, and to compare the variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-29
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-29
• Last Update Submitted: 2013-05-29
• Study First Posted: 2013-06-04
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Male or female, aged 18 to 60
• Ability to give informed consent.
• Be willing and able to use the study-provided phone for taking and transmitting capsule photos.

Exclusion Criteria

• Unwilling or unable to use a cell phone.
• Any medical, psychiatric, or other condition that, in the opinion of the investigator, would preclude safe, consistent, or useful participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval	+ 1, 2, 3, 4, 6 hours post dose

Trial Locations

Locations (1)

Addiction & Pharmacology Research Lab, St. Luke's Hospital; 🇺🇸 San Francisco, California, United States